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CTRI Number  CTRI/2024/11/077213 [Registered on: 21/11/2024] Trial Registered Prospectively
Last Modified On: 07/11/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   comparison of two physical therapy approaches that can give relief from pain experienced by female population during menstrual cycle and also relating it with low back pain to improve their quality of life 
Scientific Title of Study   Efficacy of myokinetic active release of trigger points versus dry cupping to reduce back pain and improve quality of life in reducing dysmenorrhea: a randomized clinical trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lobsang Chonzom 
Designation  PG Student 
Affiliation  LOVELY PROFESSIONAL UNIVERSITY 
Address  Lovely Professional University, School Of Allied Medical Sciences, Department Of Physiotherapy, Jalandhar, Punjab

Jalandhar
PUNJAB
144411
India 
Phone  08729926703  
Fax    
Email  sweetchonzuaa.21@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Aman Navneet Kaur(PT) 
Designation  Assistant Professor 
Affiliation  LOVELY PROFESSIONAL UNIVERSITY 
Address  Lovely Professional University, School Of Allied Medical Sciences, Department Of Physiotherapy, Jalandhar, Punjab

Jalandhar
PUNJAB
144411
India 
Phone  8054304902  
Fax    
Email  dr.amannavneet@gmail.com  
 
Details of Contact Person
Public Query  
Name  Lobsang Chonzom 
Designation  PG Student 
Affiliation  LOVELY PROFESSIONAL UNIVERSITY 
Address  Lovely Professional University, School Of Allied Medical Sciences, Department Of Physiotherapy, Jalandhar, Punjab
Jalandhar

PUNJAB
144411
India 
Phone  08729926703  
Fax    
Email  sweetchonzuaa.21@gmail.com  
 
Source of Monetary or Material Support  
Department Of Physiotherapy, School Of Allied Medical Sciences, Lovely Professional University, Jalandhar, Punjab,144411  
 
Primary Sponsor  
Name  Lobsang Chonzom 
Address  School of Allied Medical Sciences, Department of Physiotherapy, Lovely professional University, Grand Trunk (GT) road, Jalandhar, Kapurthala district, Punjab,144411 
Type of Sponsor  Other [SELF] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
DrLobsang ChonzomPT  LOVELY PROFESSIONAL UNIVERSITY  School of Allied Medical Sciences, Department of Physiotherapy OPD, Block 3, Room no.105
Jalandhar
PUNJAB 		 08729926703

sweetchonzuaa.21@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
LPU, INSTITUTIONAL ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: X||New Technology,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dry cupping therapy  Dry cupping therapy is an ancient form of healing where the patient’s skin is suctioned in a specific location using a vacuum without any stabbing or bleeding. It has been noted that cupping therapy stimulates the peripheral nervous system, increase blood flow to paralyzed muscles and skin, lift connective tissue and break adhesions, and remove excess fluids and toxins. Dosage:Two cups on the lower back one on each side of the spine and another on the suprapubic area for 10–15 min for 3 days a week 7 days before the next speculated date of menstruation. 
Intervention  Myokinetic Active release of trigger points.   Myokinetic active release technique is a soft tissue release technique where the subject is asked to actively move the tissues while deep tension is applied over the soreness. This will be administered to one group of intervention consisting of 23 female subjects. The main focus will be on three main muscles,that is Quadratus Lumborum, Rectus Abdominis and Gluteus Medius. Dosage: 5 strokes on each side (muscles) 3 days a week 7 days before the next speculated date of menstruation. 
 
Inclusion Criteria  
Age From  17.00 Year(s)
Age To  30.00 Year(s)
Gender  Female 
Details  1)Females of 17-30 years of age.
2)Subjects experiencing dysmenorrhea.
3)Subjects willing to volunteer for Physiotherapy treatment.
4)Subjects having trigger points in rectus abdominis, quadratus lumborum and gluteus medius.
5)Subjects having regular menstrual cycle. 
 
ExclusionCriteria 
Details  1)Fever
2)Inflammatory disease
3)Adenomyosis
4)Polyps
5)Fibroids
6)Post-natal dysmenorrhea
7)Endometriosis
8)Malignancy
9)Oral contraception
10)Ovarian cysts
11)Intrauterine devices
12)Cervical stenosis
13)Any other gynecological conditions
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Visual Analogue Scale(VAS)
 		 Visual Analogue Scale will be assessed at baseline and after the onset of next speculated menstrual period(after 4 weeks)
 
 
Secondary Outcome  
Outcome  TimePoints 
Menstrual Distress Questionnaire (MEDI-Q)  Menstrual Distress Questionnaire(MEDI-Q) will be evaluated at the baseline & after the onset of next speculated menstrual period(after 4 weeks) 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   24/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Dysmenorrhea(painful menstruation)has been prevalent as shown by literature review, therefore it was stated that not much of RCTs has been performed in this particular subject area, also there has been documentation done that Dysmenorrhea is related with low back pain as well particularly involving trigger points in Quadratus Lumborum, Rectus Abdominis and Gluteus Medius musculature as both pelvic area and low back muscles are supplied by same nerve root by its autonomous and peripheral parts. This study will be a comparative study between two Physiotherapy techniques, out of both which shows more efficacy in reducing back pain which will eventually impact Dysmenorrhea and increase the quality of life in young females has been aim and objective of the study. If proven otherwise, the results of the study can be informative for other Physiotherapy community and industrial stakeholders which can be implemented on masses ad can putt light on less explored female-based issues, Dysmenorrhea being one of many. 
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